MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: no patient involvement.A2: age & date of birth: no patient involvement.A3: patient sex: no patient involvement.A4: weight: no patient involvement.A5: ethnicity: no patient involvement.A6: race: no patient involvement.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: phone number: requested, unknown.E3: occupation: central complaint vigilance analyst.The actual device is not available for return; therefore, the actual condition of the actual sample was unable to be determined.Retention samples were visually inspected and confirmed free from any tilted cannula, bent cannula, or damage on cannula that might lead to the complaint.A total of five (5) complaints were received from the previous two (2) fiscal years to the present for the same issue where the cause was not identified related to our product and production process.The root cause of the complaint could not be identified to be related to our production or process.A review of the product's lot history file revealed no issues that were encountered during the production of the reported lot and the retention samples met the required specifications.Our cannula is supplied with raw material that complies with iso 9626, particularly on stiffness and breakage.The retention samples were confirmed visually in good condition.Simulation was conducted on the samples wherein the needle did not break even after 40 times bending which indicates that our needles have high resistance to breakage.We have an online and in-process visual inspection to check bent or damage to the cannula that might lead to a complaint.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.
Event or Problem Description
The user facility reported that before injection the involved terumo surguard3 safety needle was found broken.Treatment was stopped.The event occurred pre-treatment.There was no patient involvement.

• Brand Name: TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna, binan ; RP
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17629040
• Report Number: 3003902955-2023-00039
• Device Sequence Number: 15358031
• Product Code: FMI
• UDI-Device Identifier: 34806017507771
• UDI-Public: 34806017507771
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K113422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SG3+2051
• Device Lot Number: 220115C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 08/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown